NAPROXEN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

NAPROXEN SODIUM

Disponible desde:

PERRIGO INTERNATIONAL

Código ATC:

M01AE02

Designación común internacional (DCI):

NAPROXEN

Dosis:

220MG

formulario farmacéutico:

TABLET

Composición:

NAPROXEN SODIUM 220MG

Vía de administración:

ORAL

Unidades en paquete:

200

tipo de receta:

OTC

Área terapéutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0113934003; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2021-05-28

Ficha técnica

_ _
_Naproxen Sodium Product Monograph _
_Page 1 of 31_
PRODUCT MONOGRAPH
NAPROXEN
Naproxen Sodium Tablets USP
220 mg Tablets and Caplets
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
Perrigo
®
International
515 Eastern Ave.
Allegan, MI 49010
USA
Date of Preparation:
January 10, 2012
Submission Control No: 133440
_ _
_Naproxen Sodium Product Monograph _
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
....................................................................................................